Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Fotemustine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

15 mg/kg intravenously on day 1 of every 3 week cycle

bevacizumab [Avastin]

100 mg/m² intravenously on Days 1, 8, and 15, followed by 4 weeks of rest, then every 21 days up to 4 to 6 cycles

fotemustine

Clinical Trials

This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously\[IV\]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma

An Open-label Study to Assess the Anti-tumor Activity of Avastin in Combination With Fotemustine as First-line Therapy in Patients With Metastatic Melanoma

The percentage of participants with an objective response, defined as achieving CR or PR, as evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.

The percentage of participants with an objective response of CR, PR, or SD, as evaluated by RECIST criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pregressive disease (PD). The clinical benefit was finally assessed by computing absolute frequencies and percentages participants with best overall tumor response equal to CR, PR, or SD.

TTP was defined as the time in days from the date of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censured at the end of the observation period.

TTP was defined as the time in days from the of first study treatment until the date of tumor progression or death. Failure events were defined as occurrence of death or progression of disease. Data for participants who were alive without tumor progression at the end of the study were censored at the end of the observation period. Median TTP was estimated using the Kaplan-Meier method.

Evaluated only for participants whose best overall response was CR. The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.

The start date was the date of first documented CR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR was estimated using the Kaplan-Meier method.

The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.

The start date was the date of first documented CR or PR and the end date was defined as the date of first documented progression of disease. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR or PR was estimated using the Kaplan-Meier method.

Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up.

Stable disease was defined as achieving CR, PR, or SD. The start date was the date of first documented CR, PR, or SD and the end date was defined as the date of first documented progression of disease, or death. Participants who did not experience progression of disease were censored at last tumor assessment date or at maximum follow-up. Median duration of CR, PR, or SD was estimated using the Kaplan-Meier method.

OS was defined as the time from the starting day of the therapy up to death or the last date the participant was known to be alive.

The time from the starting day of the therapy up to death or the last date the participant was known to be alive. Median OS was estimated using the Kaplan-Meier method.

The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than 'Protocol Violation' or 'Administrative Problem'. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment.

The time from date of start of treatment to the earliest among date of progression, date of death due to any cause, or date of discontinuation due to reason other than 'Protocol Violation' or 'Administrative Problem'. For the participants who did not experience treatment failure, TTF was censored at last adequate tumour assessment. Median TTF was estimated using the Kaplan-Meier method.

The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up.

The time between date of start of treatment until first documented CR. This analysis included all responders. Participants who did not achieve a confirmed CR were censored at last adequate tumour assessment date or at maximum follow-up. Mean time to CR was estimated using the Kaplan-Meier method.

The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumour assessment date or at maximum follow-up.

The time between date of start of treatment until first documented response of CR or PR. This analysis included all responders. Participants who did not achieve a confirmed CR or PR were censored at last adequate tumor assessment date or at maximum follow-up. Mean time to CR or PR was estimated using the Kaplan-Meier method.

Hoffmann-La Roche

Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m\^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.

Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.

Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m\^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.

Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity.

Bevacizumab + Fotemustine

Age, Continuous

Sex: Female, Male

Safety Population: all participants who signed the informed consent form, were assigned a study patient number, and took at least one dose of each drug of study combination.

Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.

Medical Communications

Intent-to-Treat (ITT) Population: all participants who signed the informed consent form and were assigned a study patient number; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.

Percentage of Participants With Complete Response (CR) or Partial Response (PR)

ITT population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.

Time to Progression (TTP) - Percentage of Participants With an Event

TTP - Time to Event

ITT population; only participants with a best overall response of CR were included in the analysis.

Duration of CR - Percentage of Participants With an Event

ITT population; only participants with a CR were included in the analysis

Duration of CR - Time to Event

ITT population; only participants with a best overall response of CR or PR were included in the analysis.

Duration of Overall Response of CR or PR - Percentage of Participants With an Event

Percentage of Participants With Clinical Benefit of CR, PR, or Stable Disease (SD)

Duration of Overall Response of CR or PR - Time to Event

ITT population; only participants with a best overall response of CR, PR, or SD were included in the anlaysis.

Duration of Stable Disease - Percentage of Participants With an Event

ITT population; only participants with a best overall response of CR, PR, or SD were included in the analysis.

Duration of Stable Disease - Time to Event

Overall Survival (OS) - Percentage of Participants With an Event

OS - Time to Event

ITT Population; data for 1 participant were not assessable as the participant was discontinued from the study due to a protocol violation.

Time to Treatment Failure (TTF) - Percentage of Participants With an Event

TTF - Time to Event

Time to CR - Percentage of Participants With an Event

ITT population; only participants with a CR were included in the analysis.

Time to CR - Time To Event

Time to Overall Response of CR or PR - Percentage of Participants With an Event

ITT Population; only participants with a response of CR or PR were included in the analysis.

Time to Overall Response of CR or PR - Time to Event

Cycle 1 (3-week cycle): Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 and fotemustine 100 mg per square meter (mg/m\^2) IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.

Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.

Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m\^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.

Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity.

Spots Global Cancer Trial Database for A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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